Federal Regulatory Affairs Manager

1 month ago

Columbia, United States Certis Biologicals Full time

Certis Biologicals is currently seeking a highly motivated individual to join the Regulatory Affairs team as a Federal Regulatory Affairs Manager. The Federal Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all Certis Biologicals products.


Certis Biologicals is a pioneer and world leader in the development, manufacture, and distribution of biological pesticides. Certis Biologicals is an innovator in neem extracts (azadirachtin and clarified hydrophobic extract of neem oil), Bacillus thuringiensis bioinsecticides, Baculovirus technologies, and pathogenic and pesticidal fungi technologies.


The Regulatory Affairs team is responsible for obtaining and maintaining regulatory approvals for Certis Biologicals line of biopesticides, and works in partnership with Field Development, Marketing and Sales, and others inside and outside the company to support our expanding global biopesticide business. The Regulatory Affairs team secures product approvals in the United States (including the individual States and territories), other NAFTA countries (Canada and Mexico), as well as the rest of the world (Europe, Africa, Middle East, Asia, and Latin America).


The Federal Regulatory Affairs Manager is responsible for oversight, planning, and management of registration submissions with a focus on US Federal product registrations. This includes strategic planning, issue management, product compliance, and legislative tracking as well as overall management of regulatory submissions to meet regulatory and commercial deadlines, ensure freedom to operate, and maintain the highest level of regulatory compliance.


This fast-paced and timeline-driven position is located at Certis Biologicals headquarters in Columbia MD. The position may require domestic travel. The successful candidate must be detail-oriented with exceptional organizational skills and possess extensive expert knowledge of US Federal Pesticide Regulatory Affairs requirements and practices to ensure deadlines and standards are met.


The Federal Regulatory Affairs Manager will collaborate closely with the North America Team Leader and business-lead Vice Presidents to develop regulatory strategies to ensure registrations are obtained and maintained to meet business objectives and timelines.


Responsibilities include:


  • Creating processes to ensure tracking of the US Federal registrations, communicating approvals to stakeholders, and increasing efficiencies of the submission process
  • Providing direction to the business with respect to registration strategies for new and existing products ensuring that Certis Biologicals products comply with the regulations
  • Collaborating with the business teams on the identification, implementation, and management of regulatory acceptance and stewardship issues
  • Maintaining knowledge of changing US Federal and state regulatory policies and procedures to ensure compliance; assist in disseminating regulations and guidelines with appropriate interpretation
  • Planning and executing submissions that ensure timely approval of US Federal product registration in line with Marketing/Sales launch goals
  • Developing and writing clear arguments and explanations for new US Federal product registration
  • Preparing US Federal applications to maintain/support existing registrations for annual renewals and coordinating and resolving stop sale or other enforcement or product complaint situations with marketing, legal and customer service
  • Establishing and building positive relationships and points of contact with US Federal regulatory lead agencies and industry leaders to represent organizational interests and perspectives
  • Supporting Commercial Business and Supply Chain in the design, production, and management of labels and formulas for new and existing commercial products
  • Collaborating to ensure timely filings of US Federal product registrations, renewals, special assessments, and reporting requirements


Required Education and Skills/Experience:

  • Bachelor’s Degree with emphasis in chemistry, biology, agriculture, biotechnology, or related sciences
  • Three (3) or more years’ experience dealing directly with US Federal and State pesticide lead regulatory agencies
  • Knowledge of FIFRA and 40 CFR Part 150-189 registration requirements
  • Demonstrated ability to communicate effectively (both written and oral) including strong interpersonal and facilitation skills to deal effectively and tactfully with people at all levels of management, with the ability to secure action from staff and management in a matrix organization
  • Strong results orientation with the ability to think strategically while paying close attention to details
  • Strong record of consistently meeting milestones and commitments
  • Ability to develop and implement an effective and efficient regulatory submission strategy
  • Ability to travel approximately 15% of the time


Desired Education and Skills/Experience:

  • Master’s Degree in a scientific field or closely related discipline
  • Direct experience with biopesticide products
  • Prior experience working in a matrix environment
  • Knowledge of required US Federal label elements (signal words, precautionary language, personal protective equipment, and mandatory label language)
  • Prior experience analyzing complex, multidisciplinary challenges involving biopesticide regulatory and compliance issues
  • Prior experience initiating and implementing technical improvements to drive efficiency and productivity

  • Director of Regulatory Affairs

    2 months ago

    Columbia, South Carolina, United States Johns Hopkins Medicine Full time

    Job SummaryThe Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position concentrates on oversight of accreditation and certification processes,...

  • Regulatory Affairs Projects Manager

    4 weeks ago

    West Columbia, United States Nephron Pharmaceuticals Full time

    Job DescriptionJob DescriptionDescription:Regulatory Affairs Projects ManagerCorporate StatementNephron Pharmaceuticals Corporation is a privately owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron’s products are sterile, preservative and additive free and proudly made in the...

  • Director of Regulatory Affairs

    1 month ago

    Columbia, United States Johns Hopkins Medicine Full time

    Job location:Howard County Medical Center5755 Cedar Ln, Columbia, MD 21044Job SummaryThe Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This...

  • Director of Regulatory Affairs

    3 weeks ago

    Columbia, United States Johns Hopkins Medicine Full time

    Job location:Howard County Medical Center5755 Cedar Ln, Columbia, MD 21044Job SummaryThe Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This...

  • Director of Regulatory Affairs

    1 week ago

    Columbia, United States Johns Hopkins Medicine Full time

    Job Summary The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position concentrates on oversight of accreditation and certification...

  • Head of Compliance and Regulatory Affairs

    1 week ago

    Columbia, South Carolina, United States Johns Hopkins Medicine Full time

    Position OverviewThe Director of Regulatory Affairs plays a pivotal role in orchestrating, managing, and assessing compliance initiatives aimed at enhancing patient safety and quality. This leadership position ensures adherence to Federal, State, and local regulatory standards while focusing on accreditation and certification processes.Key...

  • Regulatory Affairs Licensure Specialist

    4 weeks ago

    West Columbia, United States Nephron Pharmaceuticals Full time

    Job DescriptionJob DescriptionDescription:Corporate StatementNephron Pharmaceuticals Corporation is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron’s products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West...

  • Lead Manager, Regulatory Affairs Operations

    1 week ago

    West Columbia, South Carolina, United States Takeda Pharmaceuticals Full time

    **Company Overview:**At Takeda Pharmaceuticals, we are dedicated to transforming patient care through innovative specialty pharmaceuticals and exceptional patient support programs. **Position Overview:**As the Lead Manager of Regulatory Affairs Operations, you will play a pivotal role within the Vaccine Business Unit (VBU), advancing the mission of...

  • Regulatory Assistant

    1 month ago

    Columbia, United States LHH Full time

    LHH is seeking a Regulatory Assistant on a contract basis, starting immediately! The Regulatory Assistant will support the Regulatory Affairs department in ensuring that the company complies with all relevant regulations and standards. This role involves preparing and submitting regulatory documents, maintaining records, and coordinating with various...

  • Regulatory Assistant

    4 weeks ago

    Columbia, United States LHH Full time

    LHH is seeking a Regulatory Assistant on a contract basis, starting immediately! The Regulatory Assistant will support the Regulatory Affairs department in ensuring that the company complies with all relevant regulations and standards. This role involves preparing and submitting regulatory documents, maintaining records, and coordinating with various...

  • Regulatory Assistant

    1 month ago

    Columbia, United States LHH Full time

    LHH is seeking a Regulatory Assistant on a contract basis, starting immediately! The Regulatory Assistant will support the Regulatory Affairs department in ensuring that the company complies with all relevant regulations and standards. This role involves preparing and submitting regulatory documents, maintaining records, and coordinating with various...

  • Regulatory Assistant

    1 month ago

    Columbia, United States LHH Full time

    LHH is seeking a Regulatory Assistant on a contract basis, starting immediately! The Regulatory Assistant will support the Regulatory Affairs department in ensuring that the company complies with all relevant regulations and standards. This role involves preparing and submitting regulatory documents, maintaining records, and coordinating with various...

  • Head of Regulatory Compliance

    1 week ago

    Columbia, South Carolina, United States Johns Hopkins Medicine Full time

    Position OverviewThe Director of Regulatory Affairs plays a crucial role in the strategic planning, organization, execution, and assessment of compliance initiatives aimed at safeguarding patient welfare and enhancing quality standards. This leadership position is pivotal in ensuring adherence to Federal, State, and local regulatory mandates.Key...

  • Head of Regulatory Compliance

    3 days ago

    Columbia, South Carolina, United States Johns Hopkins Medicine Full time

    Position OverviewThe Director of Regulatory Affairs plays a crucial role in strategizing, executing, and assessing compliance initiatives aimed at enhancing patient safety and maintaining high-quality standards. This leadership position is pivotal in ensuring adherence to federal, state, and local regulations.Key ResponsibilitiesOversee accreditation and...

  • Regulatory Compliance Specialist

    1 week ago

    Columbia, South Carolina, United States Medpoint, LLC Full time

    The Regulatory Affairs Specialist will play a crucial role in overseeing compliance and implementing strategies to ensure that Medpoint, LLC adheres to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The specialist will ensure compliance with medical device regulations,...

  • Regulatory Compliance Specialist

    3 days ago

    Columbia, South Carolina, United States Medpoint, LLC Full time

    The Regulatory Affairs Specialist at Medpoint, LLC will play a crucial role in overseeing regulatory issues and implementing strategies to ensure adherence to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The specialist will ensure compliance with medical device regulations,...

  • Regulatory Compliance Specialist

    1 week ago

    Columbia, South Carolina, United States Medpoint, LLC Full time

    The Regulatory Affairs Specialist at Medpoint, LLC will play a crucial role in overseeing compliance with regulatory standards and implementing strategic initiatives to ensure adherence to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The specialist will ensure compliance...

  • Regulatory Compliance Specialist

    3 days ago

    Columbia, South Carolina, United States Medpoint, LLC Full time

    The Regulatory Affairs Specialist at Medpoint, LLC will play a pivotal role in overseeing regulatory compliance and the execution of strategic initiatives to ensure adherence to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The specialist will ensure compliance with medical...

  • Regulatory Compliance Specialist

    3 days ago

    Columbia, South Carolina, United States Medpoint, LLC Full time

    The Regulatory Affairs Specialist at Medpoint, LLC will play a crucial role in overseeing regulatory issues and implementing strategies to ensure adherence to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The role requires ensuring compliance with medical device regulations,...

  • Regulatory Compliance Specialist

    3 days ago

    Columbia, South Carolina, United States Medpoint, LLC Full time

    The Regulatory Affairs Specialist at Medpoint, LLC will play a pivotal role in overseeing compliance with regulatory standards and implementing strategic initiatives to ensure adherence to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The specialist will ensure compliance...